In a recent article, I said that at least 20 microcap life sciences stocks were waiting to explode once interest returned to the sector.
Investors can now add Hemogenyx Pharmaceuticals to the watch list after it achieved the near-impossible by raising $4.2 million at a time when investors have largely gone into hibernation.
This feat of ingenuity, which will fund the initial stages of a first-in-human study of the drug developer’s lead asset, HEMO-CAR-T, only tells part of the story.
The pedigree of the scientific team behind Hemogenyx’s efforts is impressive.
At the same time, interest in next-generation CAR-T (the type of therapy Hemogenyx is developing) among big pharma has seen companies like AstraZeneca, Johnson & Johnson, Abbvie and Novartis surpass the billion-dollar threshold. dollars in a milestone. and royalty payments.
The pedigree of the scientific team behind Hemogenyx’s efforts is impressive
The initial payments, which are usually a good litmus test of the “real” interest of these titans of the drug world, have been dazzling; in some cases up to 100 million dollars.
The reason? CAR-T offers something that rarely occurs to the healthcare industry: a curative treatment, showing that the world has truly moved beyond the era of once-a-day pills like statins.
Anyway, before we delve into the details of Hemogenyx’s investment case, it’s probably worth explaining what CAR-T therapy is and how it could revolutionize the treatment of cancers such as acute myeloid leukemia (AML), which is the area of interest from this UK biotech.
CAR-T, or chimeric antigen receptor T-cell therapy, redefines the battle against disease by reprogramming the body’s own natural defenses, called T cells, to recognize and kill cancer cells.
This advanced form of immunotherapy involves removing T cells from a patient, genetically modifying them to target cancer cells, and then reintroducing these improved cells into the patient’s bloodstream.
CAR-T has demonstrated notable success in fighting certain blood cancers, offering new avenues to combat previously untreatable cancers.
Despite its potential, much of the research is now focusing on the significant side effects of CAR-T therapy, while expanding its applicability to a broader range of cancers.
Hemogenyx will use the newly raised funds to bring HEMO-CAR-T to the clinic to treat AML later this year.
The open-label study will evaluate possible side effects of treating people with blood-borne diseases and evaluate how the therapy interacts with the body.
A secondary objective or “endpoint” will be whether any of the critically ill AML patients chosen for the trial respond to the CAR-T infusion.
Under strict guidelines set by the U.S. Food and Drug Administration, patients will receive individual doses a month apart, recognizing that people are being given potentially toxic cells.
Hemogenyx hopes to have results from “two, or even three patients” in time for the American Society of Hematology conference in early December.
Success at this stage would be a 30% response rate, says Dr. Vladislav Sandler, CEO and co-founder of Hemogenyx.
The research work will be carried out by a team at the University of Pennsylvania, led by Professor Nolle Frey, who has led several major CAR-T clinical trials.
The introduction was given by Professor Carl June, the “father” of CAR-T, and his colleague Dr. Saar Gill, who was involved in the preclinical research of HEMO-CAR-T.
Of the university’s involvement, Sandler said: “This is not a situation where we have paid [UPenn] to do the work. They don’t work like that. “It has been data-driven the entire time.”
While it is not a guarantee of success, it provides validation of the science behind Hemogenyx’s efforts.
The process of creating individual CAR-T treatments is so expensive that the money raised in February may be enough to dose three patients.
Hemogenyx will seek further non-dilutive funding to evaluate a cohort of around 18 patients with acute myeloid leukemia, moving it into phase II clinical evaluation.
This is key, since it is the point at which large pharmaceutical companies have influenced the sector with the agreements mentioned above.
If all of this suggests that Hemogenyx is a one-trick pony, then that would be misleading.
Before moving into the CAR-T area, his team, along with Eli Lilly, developed a breakthrough that improves bone marrow and stem cell transplantation procedures.
The approach focuses on the initial critical stages of eradicating diseased cells and replacing them with healthy ones, using a CDX bispecific antibody that is safer and more effective than traditional chemotherapy.
“We decided to do something that other people wouldn’t touch at the time,” Sandler says. This has been the theme of all Hemogenyx research: trying the hard thing.
As such, the company has created and is a leader in the field of chimeric bait receivers. Simply put, CBRs are designed to attract and trap harmful cells, such as cancer cells, by pretending to be something that harmful cells want to attach to.
Once bad cells attach to these bait receptors, the immune system can easily find and destroy them.
His research is being implemented to combat brain cancers such as glioblastoma and neurodegenerative diseases where delivering therapies across the blood-brain barrier has long been problematic.
At the same time, he is working on intranasal delivery of CBR to address airborne viral infections, an area of research related to the civil defense industry and the military.
While Sandler would not say exactly who he is speaking to, there are conversations with parties interested in helping develop the defense deployment against viral infections, the CEO confirmed.
“We are talking to institutions and agencies,” says Sandler. “There is a lot of interest and we are moving forward in these conversations.”
The big Ice Age-like freeze in the small-cap market in the UK means none of the company’s potential has been captured in the current share price, which values Hemogenyx at a bargain £21 millions.
If we accept that this is a cyclical anomaly, the rally could be dramatic, not only for the sector, but also for individual stocks like Hemogenyx.
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